For Jenny Frank, it started with a small white pill she took nearly four years ago.
“I was prescribed Levaquin for a strep infection,” she said. “I can’t compare myself to the person I was in December in 2010.”
Levaquin is one of the most commonly prescribed antibiotics on the market. Frank said it left her with persistent, painful and long-term side effects that affected her both physically and mentally.
She recalls one moment as the scariest of her life.
“About three weeks after I had stopped taking it, I started typing on the computer,” Frank said. “When I looked at what I had written it wasn’t even words.”
The Valley science teacher said it was “gibberish.”
So Frank deleted what she wrote and tried again. “Same thing… it was just random letters and numbers and things.”
When asked what she was thinking, Frank said, “I can’t even put a sentence together. Oh my god! Am I going to lose my job?”
New Warnings Needed?
Levaquin is in a class of antibiotics called fluoroquinolones.
It’s one of the most potent antibiotics approved by the Food and Drug Administration and is prescribed millions of times a year. Experts said that most Americans will take Levaquin in their lifetime.
But the ABC15 Investigators have spoken to researchers and patients across the country who believe that Levaquin carries more serious side effects than are listed on the label. They’ve filed a pair of citizen petitions this year asking the FDA to add new warnings to the label for a long list of psychiatric side effects ranging from depression to hallucinations, and also something called “mitochondrial toxicity.”
In simple terms, researchers say that means it could alter and damage the body’s cells.
Find the petitions here and here .
The ABC15 Investigators spoke with Dr. Charles Bennett who helped write the citizen petitions filed with the FDA.
Bennett, who says he’s successfully petitioned the FDA before, is with the South Carolina College of Pharmacy and the Southern Network on Adverse Reactions (SONAR).
He said he’s been analyzing the effects of Levaquin and other fluoroquinolones for three years.
Bennett said thousands of people have reported psychiatric side effects to the FDA. He also pointed to a 2013 FDA review of six different fluoroquinoles, including Levaquin, that raised the possibility of mitochondrial toxicity.
Click here to read the review. (Mitochondrial toxicity is discussed on pages 11-12)
The ABC15 Investigators have also learned that full studies are underway at the University of California – San Diego and University of Rochester to look into these side effects.
Experts: Overuse Leads to Added Risk
Jenny Frank is part of the fight to add new warnings to the label.
“There’s no reason why anyone should have to go through this if there are safer antibiotics that could be used,” she said. “This should be a last resort. Not a first line of defense.”
It’s a feeling shared by Dr. Ray Woosley, founder of CredibleMeds and a medication safety expert. He believes Levaquin and other fluoroquinolones are overprescribed.
“The FDA put out a call two years ago that says don’t overuse these drugs, but they continue to be overused,” Woosley said. “It’s like the wild west out there.”
Here’s an example: During the anthrax mail attacks in 2001, victims were prescribed the fluoroquinolone Ciprofloxacin.
“They are very potent antibiotics,” Woosley said. “We can’t take them off the market. We have got to have them available for whom they are lifesaving.”
But Woosley said that’s also why these antibiotics should not be prescribed for things like sinus infections or strep throat – like in Jenny Frank’s case.
But it happens every day and millions of times a year, adding major risk to the treatment of minor conditions, Woosley said.
“You are using antibiotics that aren’t going to do any good and they are only going to do harm,” he said. “There are numerous studies showing the harm, and there’s no question about it.”
Last year, the FDA added a warning to fluoroquinolone labels for nerve damage. In 2008, the FDA forced a black box warning because it can cause tendons to snap.
A black box warning is the highest action the FDA can take before pulling a medication off the market.
“Most people, if they knew it could have affected them, they wouldn’t have taken it,” Woosley said.
Just ask Jenny Frank.
She took eight of the 10 pills of her Levaquin prescription. She said every dose is one of regret.
“If someone said to me that you could go back in time and change one thing, I would not fill this prescription and take these pills.”
FDA and Levaquin Respond
A spokesperson for the Food and Drug Administration sent the ABC15 Investigators the following statement.
We have received the citizen petition and will respond directly to the petitioner after we review. The citizen petition and any comments on it can be found here: http://www.regulations.gov/#!docketDetail;D=FDA-2014-P-0856 .
We like to view drug labels as living documents. We work with companies to regularly update them as new safety or efficacy information becomes available.”
Janssen Pharmacueticals, the maker of Levaquin, also sent a statement.
We are aware of the Citizen Petition and we are evaluating it.
LEVAQUIN® (levofloxacin) Tablets is part of an important class of anti-infective prescription medications that have been used for more than 20 years to treat infections, including those that may be serious or life threatening. When used according to the product labeling, LEVAQUIN® has been proven to be a safe and effective medication.
Ever since it was first approved by the FDA in 1996, the LEVAQUIN® label has included warning information. You can find the current LEVAQUIN® Medication Guide for patients here: http://www.janssenpharmaceuticalsinc.com/sites/default/files/pdf/Levaquin%20Med%20Guide.pdf#zoom=100 , and the full U.S. prescribing information, including boxed warning, here: http://www.janssenpharmaceuticalsinc.com/sites/default/files/pdf/levaquin.pdf#zoom=100
All adverse event reports Janssen receives are evaluated and reported to the FDA, including reports received for these conditions.